BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5090475 · Received September 21, 2015

    Report

    Report Number
    3004123209-2015-01218
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 28, 2015
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RECORDS 64 LOG ENTRIES BETWEEN THE 12TH JUNE 2006 AND THE 24TH AUGUST 2014. THE DEVICE RECORDS 20 MANUAL POWER UPS BETWEEN THE 29TH JUNE 2006 AND THE 30TH APRIL 2013, THE LONGEST OF WHICH LASTS 1 MINUTE 27 SECONDS DURATION. ON THE (B)(4) 2013 THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO A LOW BATTERY. THE DEVICE CONTINUES TO RECORD SELF-TEST FAILS DUE TO A LOW BATTERY UP TO AND INCLUDING THE LAST LOG ENTRY ON THE 24TH AUGUST 2014. THE INVESTIGATION WAS UNABLE TO REPLICATE OR FIND ANY EVIDENCE OF THE REPORTED FAULT. THERE WERE NO TEN MINUTE MANUAL POWERS RECORDED IN THE MEMORY LOG, THEREFORE IT IS ASSUMED THE CUSTOMER RETURNED THE DEVICE IN RESPONSE TO THE FIELD SAFETY CORRECTIVE ACTION. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623872 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1